1. Field of Invention
The present invention relates generally to a catheter and more specifically to an external male urinary catheter, generally in the form of a condom, connected at the lower portion to a collection receptacle by polyethylene drainage tubing and unified at the upper portion to a supporting garment by novel and unique means made possible by a vulcanization process among essential structures.
2. Description of the Prior Art
Traditional catheterization of the urinary bladder has involved the introduction of a catheter or tube through the urethra into the bladder for the purpose of withdrawing urine.
The hazards of introducing a catheter into the bladder are sepsis and trauma. The urinary bladder is normally a sterile cavity. However, microorganisms can enter the bladder by being pushed in during insertion of the catheter. In situations where the catheter is left in place over a long period of time, organisms can also move up the catheter lumen or the space between the catheter and the wall of the urethra. The omnipresent possibility of trauma is greater in the male patient, obviously because of the greater size of the male urethra.
Mostly in an effort to prevent the introduction of microorganisms into the urinary bladder and thereby avert the precipitation of a urinary tract infection, clinicians have resorted to the use of an external or exdwelling male urinary control device, basically a condom connected to a collection receptacle by drainage tubing. Exdwelling drainage is indicated particularly if a male patient is comatose or incontinent but still able to completely empty his bladder.
Unfortunately, such external male urinary control devices, as marketed today, in themselves present several problems. First, because of their construction, being fastened to the penis by adhesive tape, a hard rubber ring, sponge, or other tightly fitting mechanism, these devices may, over an extended period of time, constrict the blood vessels of the penis and significantly reduce the flow of blood to that organ. Loss of function and tissue necrosis and its complications, i.e., gangrene, can conceivably result. Second, the ability of the patient to completely empty his bladder becomes compromised and the purpose of catheterization defeated when a consequential obstruction to the flow of urine occurs by such constriction. In addition, urinary retention due to such obstruction may cause a reflux of urine back up the tract, predisposing the patient to kidney damage, infection, and pain.
Other less threatening side effects of the constricting mechanisms described above include pain and general discomfort. Moreover, because most patients with such an external catheter are elderly, confused, or severely debilitated males, the probability of their pulling off the device is greatly increased precisely because of the pain and discomfort imposed by the device itself.
An alternative method of external male urinary control involves a supporting garment attachment. Embodiments of such devices include: (1) a garment immediately receiving a collection receptacle with a valve mechanism, (2) a garment housing an inner waterproof lining tapered at the crotch and connected to tubing or a collection receptacle, (3) a garment attached by sewing to an extension of the upper portion of an external catheter, generally in the form of a condom, the catheter itself lined with bushing to enable a tight fit, and (4) a garment with a "snap-on" conical sheath embraced by a mechanical device which promotes the flow of urine by means of negative pressure.
Still other embodiments of external male urinary control devices include: (1) a belt supporting straps attached by buttons to an external catheter of the condom type connected at the opposite end to tubing and a collection receptacle, (2) a belt supporting the upper extension of an external catheter, generally in the form of a condom, with tubing and a collection receptacle, and (3) an external catheter, essentially a condom, itself contained within a collection receptacle.
Clearly, these embodiments represent devices which are partly or entirely cumbersome, uncomfortable, painful, and which may produce constriction of proximal blood vessels in the presence of certain features, i.e., bushing. Additionally, by virtue of their bulk and positioning or basic design, these devices have not proven to be effective in guiding and containing the gravitational flow of urine, thereby fostering conditions for leakage with consequent skin damage and odor, and creating embarrassment for the patient. Other disadvantages include difficulty in application and maintenance, and lack of adjustment to body size of the patient.
The present invention is directed to the improvement of external male urinary control by maintaining the desirable quality of an external catheter of the condom type, i.e., noninvasiveness, and, at the same time, removing the inherent disadvantages of the abovementioned devices.